CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 67 enrolled
Drug / intervention
CHF 1531 pMDI +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03086460
NCT03086460Phase 2Completed
CompareCT.gov

A Randomized, Double-blind, Placebo and Active-controlled, Incomplete Block Cross-over, Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF 1531 pMDI (Formoterol Fumarate) in Asthmatic Subjects

Chiesi Farmaceutici S.p.A.·interventional·Posted Mar 22, 2017·Updated Aug 16, 2021

In Brief

A Phase 2 clinical trial evaluating CHF 1531 pMDI, Formoterol Inhalation Solution, and 1 other intervention for Asthma. Completed, enrolled 67 participants across 10 sites.

Detailed Summary

To evaluate the dose-response of different doses of CHF 1531 pressurized metered dose inhaler (pMDI) containing formoterol fumarate, on lung function and other clinical outcomes and to identify the optimal dose(s) with regard to benefit/ risk ratio for further development in the target subject population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 22, 2017
Enrollment StartSep 8, 2017
Primary CompletionJul 23, 2018
Study CompletionJul 28, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.3 years ago

Interventions

CHF 1531 pMDIdrug

Dose Response: Test one of five different doses of CHF 1531

Formoterol Inhalation Solutiondrug

Active Control

Placebo pMDIdrug

Matched Placebo